PURPOSE: To evaluate effectiveness of oral anxiolytic medication versus relaxation technique for anxiety reduction in women undergoing breast core-needle biopsy (CNB). MATERIALS AND METHODS: The institutional review board reviewed and approved the study. Informed consent was obtained from 143 consecutive women scheduled for breast CNB. Women were randomized as follows: no anxiety intervention (usual care group), relaxation therapy with an audiotape of classical music and ocean sounds during CNB (relaxation group), and 0.5-mg of alprazolam administered orally 15 minutes before CNB (medication group). Anxiety before, during, and 24 hours after the procedure was assessed with State-Trait Anxiety Inventory and self-reported visual analog scale from 0 (no anxiety) to 10 (worst anxiety). Data analysis was performed with statistical software. Descriptive statistics were computed for all variables. Group differences were determined with analysis of variance. Differences in mean values were assessed with Bonferroni multiple comparison procedure. Categorical demographic differences were assessed with chi(2) statistic. RESULTS:Preprocedural State-Trait Anxiety Inventory scores indicated that women were not inherently anxious: usual care group, score of 44.63; relaxation group, 45.74; and medication group, 49.1. Scores represented significantly elevated anxiety for women in all three groups when compared with the normative value of 35.12 (P < .0001), with no statistically significant differences between the scores of the three groups. Women in medication group reported significant reductions in anxiety (-44%) from levels determined before the procedure to levels determined during the procedure (P = .02) and significant reduction during the procedure when compared with changes in usual care (+15%) and relaxation (-8%) groups (P = .02). Women in all three groups reported significant reduction in anxiety from levels determined before the procedure to levels determined at 24 hours after it (P < .0001). There was no significant difference (P = .95) in 24-hour postprocedural anxiety levels among the three groups. CONCLUSION: Use of oral anxiolytic medication before breast CNB can significantly reduce anxiety women experience during the procedure. (c) RSNA, 2004.
RCT Entities:
PURPOSE: To evaluate effectiveness of oral anxiolytic medication versus relaxation technique for anxiety reduction in women undergoing breast core-needle biopsy (CNB). MATERIALS AND METHODS: The institutional review board reviewed and approved the study. Informed consent was obtained from 143 consecutive women scheduled for breast CNB. Women were randomized as follows: no anxiety intervention (usual care group), relaxation therapy with an audiotape of classical music and ocean sounds during CNB (relaxation group), and 0.5-mg of alprazolam administered orally 15 minutes before CNB (medication group). Anxiety before, during, and 24 hours after the procedure was assessed with State-Trait Anxiety Inventory and self-reported visual analog scale from 0 (no anxiety) to 10 (worst anxiety). Data analysis was performed with statistical software. Descriptive statistics were computed for all variables. Group differences were determined with analysis of variance. Differences in mean values were assessed with Bonferroni multiple comparison procedure. Categorical demographic differences were assessed with chi(2) statistic. RESULTS: Preprocedural State-Trait Anxiety Inventory scores indicated that women were not inherently anxious: usual care group, score of 44.63; relaxation group, 45.74; and medication group, 49.1. Scores represented significantly elevated anxiety for women in all three groups when compared with the normative value of 35.12 (P < .0001), with no statistically significant differences between the scores of the three groups. Women in medication group reported significant reductions in anxiety (-44%) from levels determined before the procedure to levels determined during the procedure (P = .02) and significant reduction during the procedure when compared with changes in usual care (+15%) and relaxation (-8%) groups (P = .02). Women in all three groups reported significant reduction in anxiety from levels determined before the procedure to levels determined at 24 hours after it (P < .0001). There was no significant difference (P = .95) in 24-hour postprocedural anxiety levels among the three groups. CONCLUSION: Use of oral anxiolytic medication before breast CNB can significantly reduce anxietywomen experience during the procedure. (c) RSNA, 2004.
Authors: Elvira V Lang; Kevin S Berbaum; Salomao Faintuch; Olga Hatsiopoulou; Noami Halsey; Xinyu Li; Michael L Berbaum; Eleanor Laser; Janet Baum Journal: Pain Date: 2006-09-07 Impact factor: 6.961